Continuous Femoral Block With Levobupivacaine 0.125% or Ropivacaine 0.2% in Elderly Patients With Femoral Fractures

Hip Fractures Clinical Trial

Official title:

Comparison Between Continuous Femoral Block With Levobupivacaine 0.125% and Ropivacaine 0.2% for Preoperative Analgesia, in Patients Over 70 Years Old, With Proximal Femoral Fractures: a Randomized, Double-blind Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03815565
• Other study ID #: 65821217.5.0000.8066
• Status: Recruiting
• Phase: N/A
• Start date: August 28, 2017
• Est. completion date: January 8, 2021

Study information

• Verified date: February 2020
• Source: Hospital Municipal Miguel Couto
• Contact: Rafael Linhares
• Phone: +55 21 981436088
• Email: rafaellinhares[@]me.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the continuous femoral block between levobupivacaine 0.125% and ropivacaine 0.2% in patients with proximal femoral fracture.These patients will be divided into 2 groups of 35 patients, one L group (levobupivacaine 0.125%) and one R group (ropivacaine 0.2%) distributed randomly, receiving continuous infusion through patient controlled analgesia (PCA) pump with the following parameters: infusion 5 ml / h, bolus 5 ml, lockout 30 min.

Description:

Pain is associated with neurohormonal stress, myocardial ischemia and delayed mobilization, thus being able to increase the hospitalization time and associated with increased postoperative mortality. Regional anesthesia through simple or continuous femoral nerve block are options for analgesia in patients with femoral fracture, as well as analgesia by venous opioids. A potential benefit of regional anesthesia is precisely to avoid the use of opioids and other general anesthetics, which in turn are also closely related to postoperative delirium. Continuous femoral block, since the preoperative period, is associated with the reduction of acute pain and opioid consumption, in patients with femoral neck fractures. There are few studies available in the literature comparing analgesic equipotency between levobupivacaine and ropivacaine in peripheral nerve blocks. In none of them, the peripheral analgesia in the femoral nerve, for proximal femoral fracture was compared.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: January 8, 2021
• Est. primary completion date: August 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• 70 years old or more

• patients with femur fracture

• physical status risk American Society of Anesthesiologists (ASA) P1 - P3

Exclusion Criteria:

• physical status ASA P4

• patients with BMI > 35

• systemic infection

• Injury or infection at the site of installation of the femoral perineural catheter

• Catheter displacement of the perineural site

• Montreal Cognitive Assessment (MoCA) < 26

• Patients operated before 24 hours of hospital admission

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Fractures, Bone
• Hip Fractures

Intervention

Procedure:
• continuous femoral block
infusion of anesthetic by PCA pump

Locations

Country	Name	City	State
Brazil	Rafael M Linhares	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Municipal Miguel Couto

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Joshi G, Gandhi K, Shah N, Gadsden J, Corman SL. Peripheral nerve blocks in the management of postoperative pain: challenges and opportunities. J Clin Anesth. 2016 Dec;35:524-529. doi: 10.1016/j.jclinane.2016.08.041. Epub 2016 Oct 20. Review. — View Citation

Morrison RS, Magaziner J, McLaughlin MA, Orosz G, Silberzweig SB, Koval KJ, Siu AL. The impact of post-operative pain on outcomes following hip fracture. Pain. 2003 Jun;103(3):303-11. — View Citation

Ritcey B, Pageau P, Woo MY, Perry JJ. Regional Nerve Blocks For Hip and Femoral Neck Fractures in the Emergency Department: A Systematic Review. CJEM. 2016 Jan;18(1):37-47. doi: 10.1017/cem.2015.75. Epub 2015 Sep 2. Review. — View Citation

Szucs S, Iohom G, O'Donnell B, Sajgalik P, Ahmad I, Salah N, Shorten G. Analgesic efficacy of continuous femoral nerve block commenced prior to operative fixation of fractured neck of femur. Perioper Med (Lond). 2012 Jun 27;1:4. doi: 10.1186/2047-0525-1-4 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intensity of individual pain episodes	Self report pain intensity in the preoperative period. Scored 0-10 (0 = no pain; 10 = pain as bad as can be)	6 hours after hospital admission
Secondary	Number of PCA firing	in each patient at time of evaluation of pain	72 hours
Secondary	Degree of satisfaction with analgesic therapy	using the 5-point rating scale (very dissatisfied, dissatisfied, neutral, satisfied or very pleased)	up to 72 hours - at the moment of surgery; or at the end of 72 hours
Secondary	Quality of sleep	very good, good, bad and very bad	up to 72 hours
Secondary	the cost of analgesic therapy	including catheters, PCA and medication in each patient	up to 72 hours
Secondary	adverse event	paresthesia, nausea, vomiting, ringing in the ear, metallic taste, convulsion or cardiac arrest	up to 72 hours